Cardiovascular outcome trial · N Engl J Med 2004
PROVE IT-TIMI 22 trial
Intensive versus moderate lipid lowering with statins after acute coronary syndromes.
The bottom line
In patients recently hospitalized for acute coronary syndrome, intensive lipid lowering with high-dose atorvastatin (80 mg) reduced death and major cardiovascular events more than standard-dose pravastatin (40 mg).
BenefitUS status: US-approved
At a glance
- Medicine
- Atorvastatin 80 mg daily (intensive therapy)
- Compared with
- Pravastatin 40 mg daily (standard therapy)
- People
- 4,162
- Who took part
- Patients hospitalized for an acute coronary syndrome within the preceding 10 days
- Design
- Randomized, designed as a noninferiority trial comparing pravastatin with atorvastatin
- Follow-up
- 18 to 36 months (mean, 24)
- Main question
- Composite of death from any cause, myocardial infarction, documented unstable angina requiring rehospitalization, revascularization (performed at least 30 days after randomization), and stroke
Main result
26.3% (pravastatin) vs 22.4% (atorvastatin) at two years; 16 percent reduction in hazard ratio favoring atorvastatin (P=0.005; 95% CI, 5 to 26 percent)
Effect on LDL cholesterol
Median LDL cholesterol achieved: 95 mg/dL (2.46 mmol/L) with pravastatin vs 62 mg/dL (1.60 mmol/L) with atorvastatin (P<0.001)
Other results
Primary composite endpoint included death from any cause, myocardial infarction, documented unstable angina requiring rehospitalization, revascularization (≥30 days post-randomization), and stroke; not broken down separately for mortality alone in the abstract.
Safety
Not reported in the abstract
In the trial's own words
“Kaplan-Meier estimates of the rates of the primary end point at two years were 26.3 percent in the pravastatin group and 22.4 percent in the atorvastatin group, reflecting a 16 percent reduction in the hazard ratio in favor of atorvastatin (P=0.005; 95 percent confidence interval, 5 to 26 percent).”
Quoted from the abstract of N Engl J Med 2004, checked word for word against PubMed. PubMed 15007110 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the PROVE IT-TIMI 22 trial find?
In patients recently hospitalized for acute coronary syndrome, intensive lipid lowering with high-dose atorvastatin (80 mg) reduced death and major cardiovascular events more than standard-dose pravastatin (40 mg).
Who was in PROVE IT-TIMI 22?
4,162 people. Patients hospitalized for an acute coronary syndrome within the preceding 10 days.
What was PROVE IT-TIMI 22's main result?
26.3% (pravastatin) vs 22.4% (atorvastatin) at two years; 16 percent reduction in hazard ratio favoring atorvastatin (P=0.005; 95% CI, 5 to 26 percent)
How much did LDL cholesterol change in PROVE IT-TIMI 22?
Median LDL cholesterol achieved: 95 mg/dL (2.46 mmol/L) with pravastatin vs 62 mg/dL (1.60 mmol/L) with atorvastatin (P<0.001)
Related trials
- CARDS (2004)In people with type 2 diabetes but no prior cardiovascular disease and no high LDL-cholesterol, taking atorvastatin 10 mg daily substantially lowered the risk of heart attacks, revascularization, and stroke, with no increase in adverse events.
- ASCOT-LLA (2003)In hypertensive patients with average or below-average cholesterol, adding atorvastatin 10 mg to antihypertensive therapy substantially reduced coronary events, stroke, and total cardiovascular events, though it did not significantly reduce all-cause mortality.
- IDEAL (2005)High-dose atorvastatin lowered LDL-C more than usual-dose simvastatin and reduced some secondary cardiovascular endpoints and nonfatal MI, but did not significantly reduce the primary composite of major coronary events or all-cause mortality after prior MI.
- TNT (2005)In patients with stable coronary disease, treating to a much lower LDL target with high-dose atorvastatin (80 mg) further reduced major cardiovascular events compared with the standard 10 mg dose, though with more liver enzyme elevations and no difference in overall mortality.
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